No Medical Purpose Does Not Necessarily Mean No MDR Regulation
EU MDR Annex XVI covers certain products without an intended medical purpose that nevertheless have risk characteristics similar to medical devices. Beauty devices entering the EU need an assessment of whether they fall within an Annex XVI group and the applicable common specifications.
What Companies Need to Assess
- Correspondence between the product category and Annex XVI
- Whether a notified body and quality-management system are required
- Risk management, clinical evaluation and post-market surveillance obligations
- Whether separate China and EU product versions are needed
This article provides general compliance information and cannot replace a formal assessment of a specific product. Regulations, classification catalogues, guidance, and enforcement practice may change; each project should rely on the rules then in effect, the actual product, and formal documents.